Retention and trial coordinator outreach in a multicenter clinical trial during covid 19

Introduction: Human subjects research requires the retention of enrolled patients in order to provide accurate data. The COVID-19 pandemic introduced unique challenges for clinical trial coordination. AtRial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke (ARCADIA) is an NIH StrokeNet national clinical trial designed to test superiority of apixaban over aspirin for secondary stroke prevention in patients with cryptogenic stroke and atrial cardiopathy. We sought to explore the methods that allowed our site to maintain a high retention rate in our local ARCADIA population. Methods: Prior to COVID-19, our trial coordinator (JP), conducted home visits to enroll and complete study visits every 3 months for the first year. This was approved by our local institution, IRB and study sponsor. During COVID-19 precautions, phone contact was maintained and encouraged. Face-to-face visits were not possible, but our coordinator continued to deliver study drug while maintaining distancing precautions. This was followed by a phone call to remind patients of drug instructions and dosages, and inquiring about any adverse events that may have occurred since the last visit. We evaluated the number of follow up visits before and during the COVID lockdown (March through June 2020). Results: Enrollments decreased during the pandemic, in large part due to a study-wide pause in recruitment efforts. The median monthly follow-up prior to COVID-19 was 3, and increased to 5 during lockdown. Before, during and after COVID, our local retention rate has remained 100%. Conclusions: In conclusion, despite complicating factors of COVID-19, our local coordinator's retention rate remained 100% during the COVID-19 pandemic and our median number of monthly follow up visits increased, which may be attributable to our coordinator's efforts of socially distanced home visits and frequent communication.

Stroke network performance during COVID-19 pandemic: A meta-analysis

Background and Aims: The effect of the COVID pandemic on stroke networks performance are unclear, particularly with consideration of drip & ship versus mothership models. We systematically reviewed and metaanalyzed variations in stroke admissions, rate and timing of reperfusion treatments during the COVID pandemic versus the prepandemic timeframe. Methods: The systematic review followed registered protocol (PROSPERO-CRD42020211535), PRISMA and MOOSE guidelines. We searched MEDLINE, EMBASE and Cochrane CENTRAL until 9/10/ 2020, for studies reporting variations in ischemic stroke admissions, treatment rates and timing in COVID vs control-period. Primary outcome was the weekly admission incidence rate ratio (IRR=admissions during COVID-period/admissions during control-period). Secondary outcomes were (i) changes in rate of patients undergoing reperfusion treatment and (ii) time metrics for pre-and in-hospital phase. Results: Twenty-nine studies were included in qualitative synthesis, with 212960 patients observed for 532 cumulative weeks (325 control-period, 207 COVID-period). COVID-period was associated with a significant reduction in stroke admission rates (IRR=0.69, 95%CI, 0.61-0.79) and a higher relative presentation with large vessel occlusion stroke (RR=1.62, 95%CI, 1.24-2.12). Proportions of patients treated with intravenous thrombolysis remained unchanged, while endovascular treatment increased (RR=1.14, 95%CI, 1.02-1.28). Onset-to-door time was longer for drip&ship compared to mothership model (+32 minutes vs-12 minutes, pmeta-regression =.03). Conclusions: Despite a 35% drop in stroke admissions during the pandemic, proportions of patients receiving reperfusion and time-metrics were not inferior to control-period, justifying allocation of resources to keep stroke networks up and running.

Update on regional stroke activation trends during COVID-19 mitigation

Background: The University of Cincinnati Stroke Team provides acute stroke care to the southwest Ohio, northern Kentucky, and southeast Indiana catchment area of ∼2 million people and 30 healthcare facilities. We previously published a significant decline in stroke activations and reperfusion treatment (IV thrombolysis and EVT) rates following state announcements of COVID-19 mitigation measures. Here, we update these trends after state reopening guidelines. Methods: We compared Stroke Team activations and reperfusion treatments logged in a prospectively collected database, comparing the same period in 2020 versus 2019. Kentucky and Ohio announced school and restaurant closures on March 12 and 13, respectively, followed by Indiana. A stepwise reopening of our tristate area started on May 1, 2020. We also compared trends in activations and treatment rates before (Weeks 1-10), during (Weeks 11-17), and after (Weeks 18- 26) the lifting of COVID-19 mitigation efforts using the Poisson test, and graphically with segmented regression analysis. Results: Compared to 2019, stroke team activations declined by 12% in 2020 (95% CI 7 - 16%;p<0.01). During 2020, an initial decline in stroke activations following COVID-19 mitigation announcements was followed by a 28% increase in activations after reopening (Weeks 18-26: 95% CI 15 - 42%;p<0.01). In contrast, compared to 2019, treatment rates were unchanged (0%, 95% CI -15 - 18%;p=1.00), including specifically IV thrombolysis and thrombectomy rates. Similarly, an initial decline in reperfusion treatments was followed by a 24% nonsignificant increase after reopening (95% CI -10 - 71%;p=0.19) in 2020. Conclusion: The initial decline in stroke team activations during COVID-19 mitigation efforts was followed by an increase in activations after reopening. Hospital capacity and 911 services remained fully intact, suggesting that the reduction in activations were related to reduced presentation by patients for emergent stroke care.(Figure Presented).